Neoadjuvant ChemotherapyPhase 3MATRIXNCT06998758
Megestrol Acetate in Improving Neoadjuvant Chemotherapy-Related Weight Loss in Locally Advanced CRC
A Phase 3 study testing Megestrol Acetate in people with Neoadjuvant Chemotherapy and Weight Loss, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Cancer-associated anorexia, a debilitating condition characterized by progressive appetite loss in oncology patients, contributes to pancytopenia, sarcopenia, and adipose tissue depletion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neoadjuvant Chemotherapy, Weight Loss
- What is being tested?
- Megestrol Acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2025to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males and females aged between 18 and 75 years old.
- Histologically confirmed colorectal adenocarcinoma.
- Immunohistochemistry showing pMMR or MSI status determined as MSS.
- Clinical stage cTxN1-2M0, with or without MRF positivity, and with or without EMVI positivity.
- ECOG performance status 0-1, with a life expectancy of ≥6 months.
- Deemed suitable for preoperative mFOLFOX6 neoadjuvant chemotherapy following multidisciplinary team discussion.
- Written informed consent has been obtained from the patients.
Who cannot join
- Patients with cardiac arrhythmias requiring anti-arrhythmic treatment (excluding β-blockers or digoxin), symptomatic coronary artery disease or myocardial ischemia (myocardial infarction within the past 6 months), or congestive heart failure greater than NYHA Class II.
- Patients with poorly controlled severe hypertension.
- Patients with a history of HIV infection or active chronic hepatitis B or C (with high-copy viral DNA).
- Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to screening.
- Patients with other active severe clinical infections (per NCI-CTC v.5.0).
- Patients who have previously received chemotherapy.
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- Patients with a history of seizures requiring treatment (e.g., steroids or anti-epileptic therapy).
- Patients with drug abuse or medical, psychological, or social conditions that may interfere with study participation or outcome assessment.
- Patients with a known or suspected allergy to the study drug or any agents administered in relation to the trial.
- Patients with any unstable condition that may jeopardize patient safety or compliance.
- Pregnant or breastfeeding women, or fertile women not using adequate contraception.
- Patients who refuse to sign the informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital of Sun-Yat sen University
Guangzhou, Guangdong, 510065
Jun Huang, MD., +86-13926451242, huangj97@mail.sysu.edu.cn
About this study
Official title: Megestrol Acetate in Improving Neoadjuvant Chemotherapy-Related Weight Loss in Patients With Locally Advanced Colorectal Cancer: A Multicenter Randomized Controlled Clinical Trial
Cancer-associated anorexia, a debilitating condition characterized by progressive appetite loss in oncology patients, contributes to pancytopenia, sarcopenia, and adipose tissue depletion. Megestrol acetate (MA) improves appetite and promotes weight gain through multiple mechanisms, playing a crucial role in the nutritional management of cancer patients. Total mesorectal excision (TME) following neoadjuvant chemotherapy has become the standard treatment strategy for patients with locally advanced colorectal cancer (LACRC). Despite its oncological benefits, neoadjuvant chemotherapy frequently induces grade ≥2 gastrointestinal toxicities (including nausea, emesis, and diarrhea) that exacerbate malnutrition through appetite suppression and negative energy balance. Previous studies have demonstrated that combining MA with first-line maintenance chemotherapy in patients with metastatic colorectal cancer significantly improves appetite, increases body weight, enhances quality of life, and improves prognosis. However, the safety and efficacy of MA during the neoadjuvant treatment phase of LACRC remain unclear. This multicenter, randomized controlled clinical trial aims to evaluate the effects of MA on chemotherapy--related weight loss, anorexia, nutritional status, and chemotherapy tolerance in patients with LACRC undergoing neoadjuvant chemotherapy. Additionally, this study will assess the safety profile of MA in this clinical setting.
Read the detailed description
This clinical trial is an open-label, prospective, multicenter, randomized study. The aims of this study are to evaluate the effects of megestrol acetate (MA) on ameliorating neoadjuvant chemotherapy-related weight loss, anorexia, nutritional deterioration, andChemotherapy-related adverse events in patients with locally advanced colorectal cancer (LACRC), while comprehensively assessing its safety profile. Eligible participants will be randomly assigned in a 1:1 ratio to either the experimental group or the control group. Participants in the experimental group will receive 6 cycles of neoadjuvant chemotherapy regimen of mFOLFOX6 (intravenous oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5-fluorouracil 400 mg/m2, and 5-fluorouracil 2400 mg/m2 continuous pumping for 48 hours) administered every 14 days, combined with oral MA suspension at a dose of 625 mg/day. MA treatment will be maintained until the completion of neoadjuvant chemotherapy. Participants in the control group will receive 6 cycles of the mFOLFOX6 neoadjuvant chemotherapy regimen without concurrent administration of MA. Subjects in both the experimental and control groups will undergo radical surgical treatment after completing the neoadjuvant therapy. Those achieving pCR based on postoperative pathology will be regularly followed up according to the follow-up protocol. Participants who do not achieve pCR will receive six cycles of adjuvant therapy after surgery, followed by regular follow-up assessments as outlined in the protocol after completing the final cycle of adjuvant therapy. The primary outcome of this study is the incidence of weight loss (defined as >5% body weight reduction during neoadjuvant therapy). Secondary objectives include: 1) Appetite evaluation; 2) Nutritional parameter dynamics; 3) Quality of life (QoL) assessment with the EORTC QLQ-C30 questionnaire; 4) Incidence of neoadjuvant chemotherapy-related adverse events; 5) Oncological response; 6) Surgical morbidity; 7) Postoperative recovery metrics: time to first flatus/bowel movement, length of postoperative hospitalization, and 30-day readmission rates; 8) Survival outcomes: 1-year disease-free survival (DFS), Overall survival (OS).
- Conditions
- Neoadjuvant Chemotherapy, Weight Loss
- Being tested
- Megestrol Acetate
- Keywords
- Megestrol Acetate
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Megestrol AcetateDrug
Oral megestrol acetate at 625 mg/day is given from the beginning to the end of neoadjuvant chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| mFOLFOX6 + Megestrol Acetate | Experimental | Patients from experimental group receive six cycles of neoadjuvant chemotherapy with mFOLFOX6 (oxaliplatin 85 mg/m², leucovorin calcium 400 mg/m², fluorouracil 400 mg/m², and fluorouracil 2400 mg/m² continuous infusion over 48 hours on day 1) every 2 weeks and megestrol acetate at 625 mg/day by oral until the end of neoadjuvant chemotherapy. Receives: Drug: Megestrol Acetate |
| mFOLFOX6 | No intervention | Patients from this group receive six cycles of neoadjuvant chemotherapy with mFOLFOX6 (oxaliplatin 85 mg/m², leucovorin calcium 400 mg/m², fluorouracil 400 mg/m², and fluorouracil 2400 mg/m² continuous infusion over 48 hours on day 1) every 2 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of weight loss
the rate of weight loss
Measured: 1 year
Secondary outcomes (11)
Appetite assessment
Questionnaire to assess appetite of patients based on the FAACT-A/CS(Functional Assessment of Anorexia/ Cachexia Therapy) scale. A total score of more than 37 indicates a good appetite. A total score of 37 or less suggests loss of appetite, with lower scores indicating more severe anorexia.
Measured: 1 year
Changes in nutritional indicators
Nutritional indicators including serum albumin and pre-albumin
Measured: 1 year
Quality of life assessment
questionnaire to assess quality of life based on the EORTC(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) QLQ-C30 scale，ranged from 0 to 100. The higher the patient's score, the better their quality of life.
Measured: 1 year
AEs related to NCT
Incidence of adverse events related to neoadjuvant chemotherapy
Measured: 1 year
Tumor response assessment of neoadjuvant chemotherapy
Standardized framework for evaluating the efficacy of cancer treatments by RECIST 1.1
Measured: 1 year
AEs related to surgery
Incidence of adverse events related to surgery
Measured: 1 year
Time to first flatus
Time to first flatus after surgery, indicator of postoperative recovery
Measured: 1 year
Time to first defecation
Time to first defecation after surgery, indicator of postoperative recovery
Measured: 1 year
Postoperative hospital stays
Duration in hospital after surgery, indicator of postoperative recovery
Measured: 1 year
1 year of DFS
1-year disease-free survival
Measured: 1 year
1 year OS
1-year overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start11 Nov 2025
- Primary completion10 May 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant ChemotherapyStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Huang, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Jun Huang, PhD., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998758
- Sponsor's protocol ID
- E2025078
- Acronym
- MATRIX
- Status last verified
- Dec 2025
- First submitted
- 8 May 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Megestrol Acetate in Improving Neoadjuvant Chemotherapy-Related Weight Loss in Patients With Locally Advanced Colorectal Cancer: A Multicenter Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06998758
- Acronym / sponsor ID
- MATRIX / E2025078
- Conditions
- Neoadjuvant Chemotherapy, Weight Loss
- Keywords
- Megestrol Acetate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 10 May 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cancer-associated anorexia, a debilitating condition characterized by progressive appetite loss in oncology patients, contributes to pancytopenia, sarcopenia, and adipose tissue depletion. Megestrol acetate (MA) improves appetite and promotes weight gain through multiple mechanisms, playing a crucial role in the nutritional management of cancer patients. Total mesorectal excision (TME) following neoadjuvant chemotherapy has become the standard treatment strategy for patients with locally advanced colorectal cancer (LACRC). Despite its oncological benefits, neoadjuvant chemotherapy frequently induces grade ≥2 gastrointestinal toxicities (including nausea, emesis, and diarrhea) that exacerbate malnutrition through appetite suppression and negative energy balance. Previous studies have demonstrated that combining MA with first-line maintenance chemotherapy in patients with metastatic colorectal cancer significantly improves appetite, increases body weight, enhances quality of life, and improves prognosis. However, the safety and efficacy of MA during the neoadjuvant treatment phase of LACRC remain unclear. This multicenter, randomized controlled clinical trial aims to evaluate the effects of MA on chemotherapy--related weight loss, anorexia, nutritional status, and chemotherapy tolerance in patients with LACRC undergoing neoadjuvant chemotherapy. Additionally, this study will assess the safety profile of MA in this clinical setting.
Detailed description
This clinical trial is an open-label, prospective, multicenter, randomized study. The aims of this study are to evaluate the effects of megestrol acetate (MA) on ameliorating neoadjuvant chemotherapy-related weight loss, anorexia, nutritional deterioration, andChemotherapy-related adverse events in patients with locally advanced colorectal cancer (LACRC), while comprehensively assessing its safety profile. Eligible participants will be randomly assigned in a 1:1 ratio to either the experimental group or the control group. Participants in the experimental group will receive 6 cycles of neoadjuvant chemotherapy regimen of mFOLFOX6 (intravenous oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5-fluorouracil 400 mg/m2, and 5-fluorouracil 2400 mg/m2 continuous pumping for 48 hours) administered every 14 days, combined with oral MA suspension at a dose of 625 mg/day. MA treatment will be maintained until the completion of neoadjuvant chemotherapy. Participants in the control group will receive 6 cycles of the mFOLFOX6 neoadjuvant chemotherapy regimen without concurrent administration of MA. Subjects in both the experimental and control groups will undergo radical surgical treatment after completing the neoadjuvant therapy. Those achieving pCR based on postoperative pathology will be regularly followed up according to the follow-up protocol. Participants who do not achieve pCR will receive six cycles of adjuvant therapy after surgery, followed by regular follow-up assessments as outlined in the protocol after completing the final cycle of adjuvant therapy. The primary outcome of this study is the incidence of weight loss (defined as >5% body weight reduction during neoadjuvant therapy). Secondary objectives include: 1) Appetite evaluation; 2) Nutritional parameter dynamics; 3) Quality of life (QoL) assessment with the EORTC QLQ-C30 questionnaire; 4) Incidence of neoadjuvant chemotherapy-related adverse events; 5) Oncological response; 6) Surgical morbidity; 7) Postoperative recovery metrics: time to first flatus/bowel movement, length of postoperative hospitalization, and 30-day readmission rates; 8) Survival outcomes: 1-year disease-free survival (DFS), Overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mFOLFOX6 + Megestrol Acetate | Experimental | Drug: Megestrol AcetatePatients from experimental group receive six cycles of neoadjuvant chemotherapy with mFOLFOX6 (oxaliplatin 85 mg/m², leucovorin calcium 400 mg/m², fluorouracil 400 mg/m², and fluorouracil 2400 mg/m² continuous infusion over 48 hours on day 1) every 2 weeks and megestrol acetate at 625 mg/day by oral until the end of neoadjuvant chemotherapy. |
| mFOLFOX6 | No intervention | –Patients from this group receive six cycles of neoadjuvant chemotherapy with mFOLFOX6 (oxaliplatin 85 mg/m², leucovorin calcium 400 mg/m², fluorouracil 400 mg/m², and fluorouracil 2400 mg/m² continuous infusion over 48 hours on day 1) every 2 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult males and females aged between 18 and 75 years old.
- Histologically confirmed colorectal adenocarcinoma.
- Immunohistochemistry showing pMMR or MSI status determined as MSS.
- Clinical stage cTxN1-2M0, with or without MRF positivity, and with or without EMVI positivity.
- ECOG performance status 0-1, with a life expectancy of ≥6 months.
Key exclusion criteria (12 listed)
- Patients with cardiac arrhythmias requiring anti-arrhythmic treatment (excluding β-blockers or digoxin), symptomatic coronary artery disease or myocardial ischemia (myocardial infarction within the past 6 months), or congestive heart failure greater than NYHA Class II.
- Patients with poorly controlled severe hypertension.
- Patients with a history of HIV infection or active chronic hepatitis B or C (with high-copy viral DNA).
- Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to screening.
- Patients with other active severe clinical infections (per NCI-CTC v.5.0).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Megestrol AcetateOral megestrol acetate at 625 mg/day is given from the beginning to the end of neoadjuvant chemotherapy. | Drug | mFOLFOX6 + Megestrol Acetate |
Primary outcome
Incidence of weight loss
Time frame: 1 year
the rate of weight loss
11 secondary outcomes
Appetite assessment
Time frame: 1 year
Changes in nutritional indicators
Time frame: 1 year
Quality of life assessment
Time frame: 1 year
AEs related to NCT
Time frame: 1 year
Tumor response assessment of neoadjuvant chemotherapy
Time frame: 1 year
AEs related to surgery
Time frame: 1 year
Time to first flatus
Time frame: 1 year
Time to first defecation
Time frame: 1 year
Postoperative hospital stays
Time frame: 1 year
1 year of DFS
Time frame: 1 year
1 year OS
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Huang, PhD. principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Megestrol Acetate in people with Neoadjuvant Chemotherapy and Weight Loss, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Huang, PhD. (+86-13926451242, huangj97@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of weight loss (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.