Pre-Surgery Chemotherapy for Rectal Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Inflammatory bowel disease, MSI-H colorectal, others
No Placebo Group
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?This pilot trial studies how well active surveillance and chemotherapy before surgery work in treating participants with stage II-III rectal cancer. Active surveillance involves monitoring participants for additional tumor growth after receiving cancer treatment. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether deferring surgery after active surveillance and chemotherapy will work better in treating participants with stage II-III rectal cancer.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the treatment for rectal cancer?
Research shows that chemotherapy, when combined with radiation therapy before surgery, can significantly reduce the risk of cancer coming back in the same area. Even a partial response to this pre-surgery treatment is linked to lower chances of the cancer spreading to other parts of the body.
12345Is pre-surgery chemotherapy for rectal cancer safe for humans?
Pre-surgery chemotherapy for rectal cancer has been studied for safety, showing some common side effects like low blood cell counts, diarrhea, and nausea. These side effects are generally manageable, but severe cases can occur, so it's important to be monitored by healthcare professionals during treatment.
678910How is pre-surgery chemotherapy for rectal cancer different from other treatments?
Pre-surgery chemotherapy for rectal cancer is unique because it is given before surgery to shrink the tumor and reduce the risk of cancer spreading, which can improve the chances of successful surgery and lower the chance of cancer coming back.
211121314Eligibility Criteria
This trial is for adults with stage II-III rectal cancer who can undergo standard chemotherapy and are fit enough for potential surgery. They must have measurable disease, be able to use contraception if needed, and provide consent. Excluded are those with bowel obstruction, inability to undergo MRI, certain genetic cancer types like MSI-H, prior pelvic radiation or active treatment for other cancers.Inclusion Criteria
My diagnosis is rectal cancer confirmed by tissue examination.
My cancer can be measured or seen on scans.
My rectal cancer can be surgically removed with the goal of curing it.
+8 more
Exclusion Criteria
I am not currently receiving treatment for another cancer that would interfere with this trial's treatment.
I have had radiation therapy to my pelvic area before.
I cannot or do not want to have a pelvic MRI.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Chemoradiation
Participants receive chemoradiation treatment to achieve clinical complete response
4 months
Active Surveillance and Consolidated Chemotherapy
Participants receive active surveillance and consolidated chemotherapy in the absence of disease progression or unacceptable toxicity
4 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 5 years
Group I: 6 and 12 months, then annually for 3 years; Group II: every 3 months for 18 months, every 6 months for 2 years, then annually for 3 years
Participant Groups
The study tests the effectiveness of monitoring tumor growth (active surveillance) combined with pre-surgery chemotherapy in treating rectal cancer patients. It aims to determine if delaying surgery after these treatments leads to better outcomes compared to immediate surgery.
2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (active surveillance)Experimental Treatment4 Interventions
Participants who have achieved clinical complete response receive active surveillance and consolidated chemotherapy for up to 4 months in the absence of disease progression or unacceptable toxicity. Participants with incomplete response or regrowth of tumor, undergo surgical resection as in Group I.
Group II: Group I (surgical resection)Active Control2 Interventions
Participants who have achieved clinical complete response undergo standard surgical resection.
Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Chemotherapy for:
- Breast cancer
- Metastatic breast cancer
- Various other cancers
🇺🇸 Approved in United States as Chemotherapy for:
- Breast cancer
- Metastatic breast cancer
- Various other cancers
🇨🇦 Approved in Canada as Chemotherapy for:
- Breast cancer
- Metastatic breast cancer
- Various other cancers
🇯🇵 Approved in Japan as Chemotherapy for:
- Breast cancer
- Metastatic breast cancer
- Various other cancers
🇨🇳 Approved in China as Chemotherapy for:
- Breast cancer
- Metastatic breast cancer
- Various other cancers
🇨🇭 Approved in Switzerland as Chemotherapy for:
- Breast cancer
- Metastatic breast cancer
- Various other cancers
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
[Chemotherapy and rectal cancer]. [2018]Chemotherapy does not increase the survival time of patients treated for rectal cancer. Chemotherapy given concomitantly to radiotherapy and combined before or after radiation significantly reduces the risk of local recurrence. The sterilization of the tumour (complete pathological response) by chemotherapy is a favourable prognostic factor. New trials on optimisation of pathological complete response rates are based on using drugs effective on metastatic colorectal cancer, given prior to chemoradiotherapy and followed by a resection at least 8 weeks after the end of the radiotherapy. The level of evidence for postoperative chemotherapy is low due to lack of specific study. The indication of postoperative chemotherapy depends on the disease extent after preoperative treatment.
Even a partial pathological response is associated with lower relapse rates in patients with operable rectal cancer undergoing neoadjuvant chemotherapy. [2021]Neoadjuvant chemotherapy to treat locally advanced rectal cancer is an effective therapeutic strategy for the prevention of local recurrence and distant organ metastasis after surgery.
Rectal cancer. Treatment advances that reduce recurrence rates and lengthen survival. [2005]The risk of malignant disease arising in rectal mucosa is high. Surgery is the most effective form of treatment but results in cure in only 50% of patients. Adjuvant preoperative radiation therapy reduces the likelihood of local recurrence but does not improve survival rates. Fluorouracil is the most effective agent for adjuvant chemotherapy and slightly improves survival when given after surgery. Combining radiation therapy with chemotherapy appears to have a synergistic effect, and recent studies show that providing this combination after surgery improves survival. Future trends in the treatment of rectal cancer are expected to include expanded use of local excision to preserve anal sphincter function, preoperative use of a combination of radiation therapy and chemotherapy, perioperative use of chemotherapy combined with immunostimulating therapy, and use of tumor antibodies for diagnostic and therapeutic purposes.
Tumor response to neoadjuvant chemoradiation in rectal cancer: predictor for surgical morbidity? [2021]Increasing the rate of pathological complete remissions after neoadjuvant chemoradiation of rectal cancer has become a strategy to further improve the long-term oncological outcome of patients. This report evaluates the influence of preoperative intensified radiochemotherapy on the rate and outcome of surgical complications.
Emerging therapies for rectal cancer. [2007]Preoperative treatment with either short-course radiotherapy or chemo-radiotherapy (CRT) is used routinely in some centres to reduce local recurrence rates in patients with operable rectal cancer prior to optimal surgery. However, there is a need for new treatment strategies to further improve the outcomes of these patients, particularly with regard to survival. Advances in the treatment of metastatic disease, such as the use of combination chemotherapy with oxaliplatin and irinotecan, and the targeted agents bevacizumab and cetuximab, have led to clinical research into alternative radio-sensitizers during CRT and the novel use of neo-adjuvant (preoperative) chemotherapy prior to preoperative CRT and surgery. Whilst these remain experimental, it is likely that these will serve as a platform for developing an expanded range of treatment options so that clinicians will be better able to tailor treatment to the needs of different patients.
Evaluation of Preoperative Chemotherapy with Modified OPTIMOX-1 Plus Bevacizumab in Patients with Advanced Rectal Cancer with Factors Contraindicative of Curative Surgery. [2018]The efficacy and safety of neoadjuvant chemotherapy in patients with highly advanced rectal cancer for whom radical surgery was considered difficult were evaluated.
Prospective feasibility study to evaluate neoadjuvant-synchronous S-1 + RT for locally advanced rectal cancer: a multicenter phase II trial (UMIN ID: 03396). [2013]In Western countries, the standard treatment for locally advanced rectal cancer is preoperative chemoradiotherapy followed by total mesorectal excision. However, in Japan, the treatment results without preoperative chemoradiotherapy are by no means inferior; therefore, extrapolation of the results of preoperative treatment in Western countries to Japan is controversial. We consider that survival may be improved by preoperative chemoradiotherapy with new anticancer agents as they are expected not only to decrease the local recurrence rate but also to prevent distant metastases. We are conducting a multicentre Phase II study to evaluate the safety and efficacy of neoadjuvant chemoradiotherapy using S-1 in patients with locally advanced rectal cancer. The primary endpoint is the rate of complete treatment of neoadjuvant chemoradiotherapy. Secondary endpoints are the response rate of neoadjuvant chemoradiotherapy, short-term clinical outcomes, rate of curative resection and pathological evaluation. The short-term clinical outcomes are adverse events of neoadjuvant chemoradiotherapy and surgery-related complications. Thirty-five patients are required for this study.
Clinical comparison of QOL and adverse events during postoperative adjuvant chemotherapy in outpatients with node-positive colorectal cancer or gastric cancer. [2019]The aim of this study was to evaluate the quality of life (QOL) from the performance status (PS) and face scale (FS), and to compare adverse events (AEs) during chemotherapy in 28 patients with node-positive colorectal cancer (NP-CRC) and 15 patients with node-positive gastric cancer (NP-GC). The anticancer regimen consisted of 5-FU/LV+CPT-11 for NP-CRC and 5-FU+low-dose CDDP for NP-GC. Results were evaluated after completion of three courses. QOL evaluation revealed no significant differences between the two groups with respect to PS and FS. Among hematological AEs, grade 1/2 mild leucopenia was significantly more common in NP-CRC than NP-GC patients (p
Association of adverse events and survival in colorectal cancer patients treated with adjuvant 5-fluorouracil and leucovorin: Is efficacy an impact of toxicity? [2014]Adverse events associated with 5-fluorouracil (5FU) based adjuvant therapy in colorectal cancer (CRC) patients may predict survival. We studied whether haematological (leucopenia, neutropenia, thrombocytopenia) or non-haematological (mucositis, diarrhoea, nausea/vomiting, hand-foot syndrome or other toxicity) adverse events were associated with disease-free survival (DFS) or overall survival (OS) in a large patient material treated with 5-fluorouracil based adjuvant chemotherapy.
Chemoradiotherapy with 5-fluorouracil/leucovorin, surgery and adjuvant chemotherapy for locally advanced rectal cancer. [2021]The aim of this study was to demonstrate a pathologic complete response (pCR) rate of at least 10% with an acceptable toxicity achieved by preoperative chemoradiotherapy with 5-fluorouracil (5-FU)/leucovorin in patients with locally advanced rectal cancer. Patients were treated by radiotherapy targeting 50 Gy and 5-FU/leucovorin intravenously during the 1st, 4th and 7th week after start of radiotherapy followed by surgery and adjuvant chemotherapy. In 71 evaluable patients, the pCR rate was 14.1% (95% CI, 6.0-22.2); the local relapse rate, 6.1%; the 5-year disease-free survival, 54% and the overall 5-year survival, 68%. The most severe adverse events were neutropenia (17%), diarrhoea (17%), infection (8%) and fatal cardiovascular function (1%). This therapy yielded a high rate of pCR, a low rate of local relapse and a long disease-free and overall survival. To increase its feasibility, radiation dose reduction to 45 Gy and administration of only two preoperative cycles of chemotherapy is recommended.
Adjuvant Chemotherapy in Rectal Cancer Patients Treated With Preoperative Chemoradiation and Total Mesorectal Excision: A Multicenter and Retrospective Propensity-Score Matching Study. [2019]The role of adjuvant chemotherapy after preoperative chemoradiation therapy (CRT) and curative surgery in rectal cancer has yet to be definitely determined. We performed a retrospective and multicenter study to evaluate whether adjuvant chemotherapy (AC) could reduce recurrence and improve survival in locally advanced rectal cancer.
Analysis of Survival in Complete Pathological Response after Long-Course Chemoradiotherapy in Patients with Advanced Rectal Cancer. [2023]Neoadjuvant chemoradiotherapy prior to surgery is the standard treatment for locally advanced rectal cancer. This consists in the patient's complete pathological response being achieved with no residual tumor presence in the resected specimen, which results in survival improvement.
[Treatment Strategy for Stage Ⅳ Rectal Cancer]. [2015]Eighteen consecutive patients who underwent rectal resection following preoperative chemotherapy for cStage Ⅳ rectal cancer at our institute, between 2009 and 2014, were retrospectively assessed. Preoperative chemotherapy with mFOLFOX6, SOX, XELOX, and other anticancer agents was administered to 8, 5, 3, and 2 patients, respectively. Combined molecular targeted therapy was administered to 12 patients. The response evaluation showed that an antitumor effect was observed in 10 and 8 patients with local tumors who achieved a partial response (PR) and stable disease (SD), respectively, and in 9 and 9 patients with distant metastases who achieved a PR and SD, respectively. The operative procedures included high/low anterior resection (n=12), intersphincteric resection (n=2), and abdominoperineal resection/Hartmann's operation (n=4). An ileostomy was performed in 6 patients before chemotherapy. Postoperative complications occurred in 6 patients. Two patients with an ileostomy had anastomotic insufficiency, but recovered without reoperation. There was no significant difference in overall survival (p=0.382) when these patients were compared with 45 cStage Ⅳ rectal cancer patients who underwent surgery without preoperative chemotherapy. However, the rate of curability B was higher in patients who received preoperative chemotherapy (44.4%) compared to those who did not (26.7%). The results of this study are inconclusive and have not determined whether preoperative chemotherapy results in better long-term survival for cStage Ⅳ rectal cancer patients. However, preoperative chemotherapy might contribute to higher operative curability.
[Postoperative chemotherapy in rectal carcinoma]. [2006]The natural history of rectal carcinoma requires to achieve strategies addressed both local control and the prevention of distant metastases. Based on the NCI Consensus Conference of 1990, the recommended adjuvant treatment for rectal carcinomas staged pT3, or with pathologically involved lymph nodes, is represented by concurrent chemoradiation. The role of chemotherapy in the adjuvant treatment of patients operated on for rectal tumor remains unclear also in patients treated with preoperative chemoradiation. The chemotherapeutic drugs to be used, and the potential role of chemotherapy alone for patients at low risk of local recurrence, should also be considered. In this analysis literature data regarding these issues are presented. Despite the absence of clear indications from published data, in patients with pathological B2 or C stage after preoperative chemoradiation it seems that adjuvant chemotherapy should be used.