Comparison of Short-term Efficacy and Long-term Prognosis for Reduction Surgery and Radical Resection in Almost-cCR Rectal Cancer Patients

Zhang Rui

Status and phase: Unknown; Phase 3

Conditions: Almost-cCR; Surgery; Rectal Cancer

Treatments: Procedure: Miles surgery; Procedure: transanal surgery; Drug: Preoperative chemoradiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03431428

20171112

Details and patient eligibility

About

The aim of this study is evaluate the effect of two different surgical treatment on lower rectal cancer after almost clinical complete response(almost-cCR). All almost clinical complete response(almost-cCRs) were entered into two groups randomly. The estimated sample size of the minimal operation group was 221, and 221 in the Mile's group. Three years' progression-free survival(PFS) and overall survival(OS) were compared.

Full description

Patients with low rectal cancer were treated with neoadjuvant radiotherapy, and two cycles of XELOX at the interval. All almost-cCRs after neoadjuvant treatment were randomly divided into minimal operation group or Mile's group. All cCRs were treated with "watch and wait". Patients after local recurrence were randomly divided into minimal operation group or Mile's group. If pathological result was pathological staging 3 after neoadjuvant therapy（ypT3） in minimal operation group or local postoperative recurrence occurred, patients need supplement of abdominoperineal resection (APR). With 3 years follow-up，the main research goals are 3 years of progression-free survival(PFS) and overall survival(OS). Secondary endpoints are side effects of chemotherapy, assessment of quality of life, surgical complications, adverse prognostic factors and so on.

Enrollment: 477 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histology is confirmed as rectal adenocarcinoma.
2. 18 to 75 years old.
3. Preoperative staging is lower than clinical stage primary tumor grade 3, regional lymph node grade 1, and metastasis was grade 0（cT3cN1M0）.
4. The anus couldn't be retained after TME.
5. Almost-cCR or cCR recurrence during observation.

Exclusion criteria

1. Patients were unable to tolerate the operation.
2. Preoperative stage: T4b or progress during the treatment.
3. HIV infection stage or chronic hepatitis B.
4. Active clinical severe infections.
5. Evil liquid state or decompensation of organ function.
6. Other malignant tumor history in five years.
7. Other primary carcinoma.
8. Unstable condition and incompliance of the patient

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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477 participants in 2 patient groups, including a placebo group

transanal surgery

Experimental group

Description:

To ensure the complete cutting edge with no residual tumor, the tumor with corresponding mesorectal excision was removed by the distance edge of 1cm. The intestinal wall was sutured to ensure the integrity of the bowel.

Treatment:

Drug: Preoperative chemoradiotherapy

Procedure: transanal surgery

Miles surgery

Placebo Comparator group

Description:

According to the total mesorectal excision(TME) principle, complete mesorectum, lymph node and the anus was excised. A sigmoid colostomy was finally performed.

Treatment:

Drug: Preoperative chemoradiotherapy

Procedure: Miles surgery