RecruitingNCT03466424

Short-course Radiotherapy (5×6Gy/7Gy/8Gy) Followed by Neo-adjuvant Chemotherapy for Locally Advanced Rectal Cancer

Phase I Trial of Dose-escalation Preoperative Short-course Radiotherapy (5×6Gy/7Gy/8Gy) Followed by Neo-adjuvant Chemotherapy in Locally Advanced Rectal Cancer : the FJUHR-01 Trial


Sponsor

Fujian Medical University Union Hospital

Enrollment

9 participants

Start Date

Aug 1, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

Preoperative radiotherapy followed by total mesorectal excision (TME) has been recommended as the preferred treatment method for locally advanced rectal cancer. Similar rates of local control, survival and toxicity were observed in preoperative long-course radiotherapy (LCRT) (45-50.4 Gy in 25-28 fractions) and short-course radiotherapy (SCRT) of 25 Gy in five fractions. For the convenience of SCRT, a growing number of patients tend to receive SCRT as preoperative radiotherapy. Although SCRT can shorten treatment interval and cut down the cost of treatment, it's pathological complete response (pCR) rate is relatively low (SCRT vs. LCRT: 0.7% vs. 16%). Hence, the optimal pattern of preoperative therapy of locally advanced rectal cancer still deserves to be explored. Previous studies have confirmed the feasibility and safety of 30Gy/5 fractions in SCRT of rectal cancer and verified that SCRT followed by mFOLFOX6 chemotherapy can improve the pCR rates. Therefore, investigators aimed to establish a dose escalation mode of SCRT (5×6Gy/7Gy/8Gy) followed by four cycles of modified FOLFOX6(mFOLFOX6) chemotherapy to test the safety and efficacy in treating locally advanced rectal cancer.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a short, intense course of radiation (5 treatments over 1 week, with higher doses per session than usual) followed by chemotherapy before surgery in patients with locally advanced rectal cancer, to see if this approach shrinks the tumor better than standard treatment. **You may be eligible if...** - You are between 18 and 70 years old - You have locally advanced rectal cancer (stage T3 or T4, and/or spread to nearby lymph nodes) confirmed by biopsy, located within 12 cm of the anal opening - You have not yet received any treatment for this cancer - You are not pregnant - Your blood counts, kidney function, and liver function are all within acceptable ranges - You are well enough to function in daily life (Karnofsky score ≥70) **You may NOT be eligible if...** - Your cancer has spread to other parts of the body (distant metastases) - You are already on another cancer treatment - You have a serious heart, brain, or lung condition - You are unable to complete the full treatment course Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONpreoperative short-course radiotherapy

Patients will be enrolled into Group 1 to 3 according to the time order of entering the study to receive dose from 6Gy×5F to 8Gy×5F using the traditional 3+3 dose escalation design.


Locations(1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

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NCT03466424


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